A Scientific Evaluation of One or Two Doses of a Vaccine Against Human Papillomavirus: Long Term Follow Up of Gardasil9 Recipients in the ESCUDDO Study ("Estudio de Comparación de Una y Dos Dosis de Vacunas Contra el Virus de Papiloma Humano [VPH]")
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Human Papillomavirus-Related Malignant Neoplasm. Basic parameters: from 12 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Costa Rica
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Scientific Evaluation of One or Two Doses of a Vaccine Against Human Papillomavirus: Long Term Follow Up of Gardasil9 Recipients in the ESCUDDO Study ("Estudio de Comparación de Una y Dos Dosis de Vacunas Contra el Virus de Papiloma Humano (VPH)")
Overview
This study evaluates the long term protection provided by either one or two doses of the HPV vaccine for patients who were part of the ESCUDDO study.
Detailed description
PRIMARY OBJECTIVES:
I. To estimate the IRD and RR of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 7 to 10 years following HPV vaccination.
II. To estimate the IRD and RR of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 1 to 10 years following HPV vaccination.
OUTLINE: This is an observational study.
Patients undergo vaginal and anal swab self sample collection, blood, urine sample collection, complete questionnaires, and have their medical records reviewed on study.
Interventions
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- First type-specific occurrence of HPV6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection [Time frame: Up to study completion]
- First any-type occurrence of HPV6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection [Time frame: Up to study completion]
Eligibility criteria
Inclusion criteria
- \* Participation in ESCUDDO base study
- Randomization (excluding the two participants who had major protocol deviations in the ESCUDDO base study) to the Gardasil9 1- and 2-dose arms
- A signed informed consent form for ESCUDDO LTFU.
- Opportunity to complete three total study visits
Exclusion criteria
- \* Enrollment cannot occur beyond her 10 year study visit
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Costa Rica · 1 center
- Agencia Costarricense de Investigaciones Biomédicas (ACIB) — Liberia
Identifiers
NCT: NCT07706673 · NCI-2026-05053 · NCI-2026-05053 · 26G002-02